Brand Name | ZEUS SYSTEM |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
IRHYTHM TECHNOLOGIES, INC |
699 8th st suite 600 |
san francisco CA 94103 |
|
Manufacturer (Section G) |
IRHYTHM TECHNOLOGIES, INC |
6550 katella avenue, suite 200 |
|
cypress CA 90630 |
|
Manufacturer Contact |
mazi
kiani
|
699 8th st suite 600 |
san francisco, CA 94103
|
9494132147
|
|
MDR Report Key | 18721976 |
MDR Text Key | 336632572 |
Report Number | 3007208829-2024-00073 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K222389 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/16/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/26/2024 |
Initial Date Manufacturer Received |
01/30/2024
|
Initial Date FDA Received | 02/16/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/14/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | ZIO AT/SN: (B)(6) |
Patient Age | 78 YR |
|
|